Tofacitinib Amine Impurity\Tofacitinib Inhouse Impurity A
Descrição
A impureza N-descianoacetil de tofacitinib, também designada impureza amina de tofacitinib, é um resíduo de intermediário sintético relacionado ao processo, associado à construção da cadeia lateral do tofacitinib. CAS 477600-74-1, fórmula molecular C13H19N5 e massa molecular 245.32 g/mol, descrevem uma amina heteroaromática básica que carece da funcionalidade cianoacetil do intermediário da rota original. É normalmente monitorada como impureza de rota decorrente de acilação incompleta, desproteção ou conversão hidrolítica durante a fabricação. A quantificação geralmente requer LC-MS/MS, LC-UV com confirmação ortogonal e, por vezes, HRMS para discriminar espécies amínicas estruturalmente relacionadas em estratégias de controle de impurezas alinhadas com ICH Q3A e ICH M7.
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